8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PENICILLIN-STREPTOMYCIN-FUNGIZONE
FDA 510(k)
FDA Class 1
·Microbiology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809642377·OPAQUE MATERNITY 15-20 MM HG THIGH HIGH ZIG ZAG...
Aer-O-Scope Colonoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FOCUS VNG/ENG TYPE 1068
FDA 510(k)
FDA Class 2
·Neurology
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
SECURA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·November 8, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012